Safety and Tolerability of IPH4502 in Patients With Advanced Solid Tumors (NCT06781983) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Safety and Tolerability of IPH4502 in Patients With Advanced Solid Tumors
United States, France145 participantsStarted 2025-01-24
Plain-language summary
This is a first-in-human, open-label, multicenter, Phase 1 study to evaluate the safety, tolerability and preliminary efficacy of IPH4502 and to determine the recommended Phase 2 dose (RP2D) in advanced solid tumors that are known to express Nectin-4
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Main Inclusion Criteria:
* Histologically confirmed, unresectable, locally advanced or metastatic solid tumors that are known to express Nectin-4
* Prior systemic treatment for locally advanced or metastatic disease, yet no therapy with demonstrated clinical benefit for the tumor type is available.
* Measurable disease according to RECIST 1.1.
* Archival tumor tissue obtained within 4 months of screening and since the last anticancer therapy prior to the study or agree to undergo a tumor biopsy at baseline.
* Adequate organ function and hematological function.
Main Exclusion Criteria:
* Known or suspected brain metastases.
* Participants with an active infection, Any other infection requiring systemic treatment or latent infection.
* Participants with clinically significant comorbidity(s).
* History of treatment for, or suspicion or confirmed interstitial lung disease (ILD) at baseline.
* Condition being treated with systemic corticosteroids or immunosuppressive therapy during IPH4502 treatment.
* Thromboembolic event requiring anticoagulation therapy ≤14 days prior to the first dose of IPH4502.
* Clinically significant cardiovascular disease and/or cardiac repolarization abnormality.
* Participants with symptomatic heart failure, Acute coronary syndromes
* Participant is receiving or has received anticancer therapy prior to enrolment that may have impact on the assessment of IPH4502.
* Major surgery ≤28 days and minor surgery ≤7 days prior to first dose of IPH4502 or 6 mo…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and Tolerability
Timeframe: From time of first dose through treatment period, including the follow-up: up to 24 months